Many drugs are mixed with a diluent before being delivered intravenously to a patient. The diluent may be, for example, a dextrose solution, a saline solution or even water. Many such drugs are supplied in powdered form and packaged in glass or plastic vials. Other drugs, such as some used in chemotherapy, are packaged in glass or plastic vials in a liquid state.
In order for the powdered drugs to be given intravenously to a patient, the drugs must first be placed in liquid form. Other drugs, although in a liquid state, must first be diluted before administration to the patient. As used herein, the term reconstitution includes not only liquidization of powdered drugs but also dilution of liquid drugs.
One way of reconstituting a drug is first to inject a drug diluent into the drug vial. This may be performed by a syringe having a liquid diluent contained in the syringe barrel. After the rubber stopper of the vial is pierced by the syringe needle, the liquid is injected into the vial. The vial is shaken to reconstitute and dilute the drug with the liquid. The liquid is then withdrawn back into the syringe. These steps may be repeated several times to ensure complete reconstitution of the drug. After the final mixing, the syringe is withdrawn and the reconstituted drug may then be injected into an administration set for intravenous administration to a patient.
Another common means of drug administration is to inject the reconstituted drug from the syringe into a parenteral solution container containing a medical solution such as dextrose or saline solution. The drug, now diluted with the medical solution in the parenteral solution container, is delivered through an administration set for intravenous administration to the patient.
Another means for reconstituting a drug is a device utilizing a double pointed needle. The double pointed needle includes a guide mounted around one end of the needle to direct the needle into fluid communication with the interior of a flexible solution container via a port. The opposite side of the needle includes a skirt which fits over and grips a drug vial to establish fluid communication between the needle and the interior of the drug vial.
An improvement to this is a device in which the guide and the skirt are attached to housing which establishes slidable engagement between the guide and the skirt. This allows fluid communication to be established between a lumen defined in the housing and the interior chamber of the flexible solution container while the drug vial can be attached to the skirt without establishing fluid communication between the interior of the vial and the lumen. When reconstitution is desired, the slidable housing is slid which directs one side of the needle into the vial to establish fluid communication for reconstitution.
Still another device utilizes a dedicated drug vial which is secured to a dedicated access site in a dedicated solution container. The dedicated access site includes housing to establish fluid communication between the interior of the dedicated drug vial and the interior of the dedicated flexible solution container.
As is seen, these devices all attempt to balance sterility issues which increase in difficulty as the complexity of the device increases with the issue of efficient storage of the drug prior to reconstitution. What would thus be advantageous is a reconstitution device which effectively reconstitutes and dilutes a drug. This device should also allow for easy storage of the unreconstituted drug preferably in a standard vial. This device should further avoid complexity of parts to reduce sterility difficulties. Such device should further be cost effective to produce and administer. The present invention meets these requirements.